What is a key regulatory requirement for a biosimilar to be deemed interchangeable with its reference product?

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Interchangeability hinges on evidence that switching between the biosimilar and its reference product does not introduce extra risk. Biosimilars are highly similar to the reference biologic, but the designation of interchangeable goes beyond similarity: it requires clinical data showing that patients can switch back and forth without compromising safety or efficacy, including data on immunogenicity across switches. This is not granted automatically after first approval, and it isn’t based on manufacturing data alone. Therefore, the best choice is that interchangeability requires additional evidence showing no switching risk.